An interventional study of Mucogyne® gel in Perineal Tear and Episiotomy, sponsored by Biocodex. Recruiting at 3 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Biocodex · Not applicable, Interventional, and Other
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.
Biocodex is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
First (with cutaneous injury) and 2nd-degree perineal tear/episiotomy, whose length and depth are as the following:
Exclusion Criteria:
In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.
Device: Mucogyne® gel
Standard of care e.i no treatment
In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.
To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.
Wound healing will be assessed using the perineal healing scale after episiotomy or perineal tear, the Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale, change between baseline (48h postpartum) and 12 days postpartum days (after 10 days of application of Mucogyne® gel) will be calculated.The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3. Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2, Moderately healed from 3 to 5, Mildly healed from 6 to 8, and Not healed from 9 to 15.
Time frame: Day 0 to Day 12 (+/-2) after delivery
To describe wound characteristics
Wound characteristics will be described using the Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale sub-score at each visit. The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3. Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2, Moderately healed from 3 to 5, Mildly healed from 6 to 8, and Not healed from 9 to 15.
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess pain relief (related to the vaginal wound)
The presence of perineal pain (related to the vaginal wound) at rest, in movement, while sitting, while urinating and defecating
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the need/use of pain relieving drugs
Number of used pain-relieving drug related to the vaginal wound healing
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Change in clinical status will be assessed by Clinical Global Impressions scale, (CGI-I). The CGI was developed for use in clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Change in clinical status will be assessed by Patients' Global Impression of Change scale (PGIC). The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the patient wound cosmetic appearance
Wound cosmetic appearance will be assessed using a scale from the "worst scar" to the "best scar"
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the overall patient's satisfaction
Patient satisfaction will be assessed using Patient Satisfaction Score (PSS) rated based on scores of 0 to 10, with higher scores indicating better satisfaction and lower scores indicating poorer satisfaction.
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess re-appropriation and acceptance of the body by the patient
Re-appropriation and acceptance of the body will be assessed by a questionnaire. The body reappropriation scale is composed of 5 questions in 7 points with 1="Strongly agree" and 7="Strongly disagree". This scale looks at the patient's ability to look at her scar in a mirror, to clean it, to touch it and to massage it. One question concerns the impact of the scar's appearance on the patient's self-esteem.
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the patient perception of the Medical Device
A customized questionnaire about sensory analysis of the study product (texture, ease of spreading, softness after application, aqueous, freshness, etc.)
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess compliance with the Medical Device use
Number of days of use
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the safety of Mucogyne® gel : Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution.
Time frame: Day 0 to Day 12 (+/-2) after delivery
Plan to share: No
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